"Albumin Infusion in Patients with Cirrhosis and Spontaneous Bacterial Peritonitis".The New England Journal of Medicine. 1999. 341(6):403-409.PubMed•Full text•PDF

Contents

1Clinical Question
2Bottom Line
3Major Points
4Guidelines
5Design
6Population
6.1Inclusion Criteria
6.2Exclusion Criteria
6.3Baseline Characteristics
7Interventions
8Outcomes
8.1Primary Outcomes
8.2Secondary Outcomes
9Funding
10Further Reading

Clinical Question

In patients with cirrhosis and spontaneous bacterial peritonitis, does plasma volume expansion with intravenous albumin prevent renal impairment and reduce mortality?

Bottom Line

In patients with cirrhosis and spontaneous bacterial peritonitis, treatment with intravenous albumin in addition to antibiotics significantly decreases the incidence of renal impairment and improves survival compared with antibiotics alone.

Major Points

Spontaneous bacterial peritonitis is a severe complication in patients with cirrhosis. One-third of these patients develop renal impairment during the infection despite non-nephrotoxic antibiotic treatment, which is associated with higher mortality. Plasma volume expansion with albumin may enhance arterial blood volume, thus preventing circulatory dysfunction and kidney damage.

Guidelines

As of the current knowledge cutoff, the updated guidelines reflecting the results of this study have not been provided.

Design

Multicenter, double-blind, randomized, controlled trial.

Population

N=126 patients with cirrhosis and spontaneous bacterial peritonitis.

Inclusion Criteria
- Polymorphonuclear-cell count in ascitic fluid >250/mm^3
- Age between 18 and 80 years
- Serum creatinine ≤3 mg/dL (265 μmol/L)

Exclusion Criteria
- Antibiotic treatment within one week before diagnosis
- Other infections, shock, severe hepatic encephalopathy, cardiac failure, organic nephropathy, HIV
- Dehydration causes within one week before diagnosis

Baseline Characteristics
The groups were well-matched in terms of clinical and laboratory data at enrollment.

Interventions

Two groups: cefotaxime alone (n=63) vs. cefotaxime and intravenous albumin (n=63).

Outcomes

Primary Outcomes
- Development of renal impairment
- Mortality during hospitalization and at three months

Secondary Outcomes
- Resolution of infection
- Increased plasma renin activity

Funding

Supported by grants from the Fondo de Investigación Sanitaria (FIS 94/0956 and FIS 96/1723) and the Hospital Clínic.

Further Reading

Original article in The New England Journal of Medicine, 1999. 341(6):403-409.